Collecting KOL Insights Into Trial Design
The Challenge
A biopharmaceutical company with a novel targeted treatment in phase 1/2A wants to better understand critical success factors for their drug and obtain input on the design of the next phase of clinical trials that will satisfy both FDA regulators and physicians. Two unique genetic profiles within a specified cancer type needed to be addressed.
The IP Solution
IP organized a virtual global ad board with nine KOL advisors to address benchmarks for efficacy, goals of treatment, meaningful endpoints, and education regarding safety concerns and approaches to monitoring patients.
IP continues to be critical in our US strategy. From day one they have worked closely with [us] as an extended part of our company, understanding our challenges and working with us to find solutions putting a clear strategy in place and ultimately delivering on their word. Our relationship is incredibly strong.
The Results
The company obtained clear and actionable feedback and was given useful direction on opportunities for how best to incorporate this agent into combination regimens and how to differentiate itself from other pipeline agents with similar targets. The company was also provided with suggestions on areas of tumor biology that should be explored including the genomic, and cytogenetic profiles of responders and non-responders, the biology/features of disease progression, and the type of resistance mechanisms that may operate.
